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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM FLEXIBLE SHAFT REAMER

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SYNTHES GMBH 5.0MM FLEXIBLE SHAFT REAMER Back to Search Results
Catalog Number 352.04
Device Problem Device-Device Incompatibility (2919)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/09/2020
Event Type  Malfunction  
Manufacturer Narrative

Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the flexible reamers were used to widen the isthmus of a canal during a revision of a cemented hip stem. The cement had been removed prior to the surgeon attempting to widen the narrow isthmus for the long revision stem. The guide rod was used to ream the canal, but when the flexible shaft was removed, the reamer head was not on it. The surgeon attempted to retrieve the reamer head, but decided to leave it in situ. The procedure was completed successfully. This report is for one (1) 5. 0mm flexible shaft. This is report 2 of 3 for (b)(4).

 
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Brand Name5.0MM FLEXIBLE SHAFT
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10785367
MDR Text Key214588507
Report Number8030965-2020-08552
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/04/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.04
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 11/04/2020 Patient Sequence Number: 1
Treatment
SYNREAM FLEXSHAFT; SYNREAM REAMER HEAD Ø10; SYNREAM REAMING ROD Ø2.5 SHORT L950
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